Taiwan FDA registration 83a290d92bba9dcf37835a1a661e06c2

Saibia's third-generation capillary immunophenotyping reagent

TW: 賽比亞第三代毛細管免疫分型檢測試劑
Taiwan flagTaiwan·Risk Class 2·SEBIA·Registered Feb 07, 2020 – Feb 07, 2030Active
Registration details
Analysis ID
83a290d92bba9dcf37835a1a661e06c2
Customs Code
DHA05603326904
Company information
Manufacturer
SEBIA
Manufacturer Country
France
Authorized Representative
ARQon Medtech Co., Ltd.
Product details
Intended Use
THIS PRODUCT IS USED ON THE SEBIA CAPILLARYS 3 INSTRUMENT TO DETECT AND IDENTIFY MONOPROTEINS (IMMUNOTYPING) IN HUMAN URINE AND SERUM BY CAPILLARY ELECTROPHORESIS.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統;; C.5550 免疫球蛋白(特定輕鏈)免疫試驗系統
Import Information
import
Dates and status
Registration Date
Feb 07, 2020
Expiry Date
Feb 07, 2030
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About this record

Access comprehensive regulatory information for Saibia's third-generation capillary immunophenotyping reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 83a290d92bba9dcf37835a1a661e06c2 and manufactured by SEBIA. The authorized representative in Taiwan is ARQon Medtech Co., Ltd..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SEBIA, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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